FDA Launches TEMPO, a Pilot Program for Generative AI Medical Devices

The system allows some manufacturers to market their products in real conditions before full approval, in exchange for close supervision by the agency.

At the beginning of September, the Food and Drug Administration launched TEMPO, a pilot program designed to give its teams practical experience with medical devices based on generative AI in real-world conditions. The system authorizes certain developers, on a provisional basis, to put their product on the market before the traditional approval process has been fully completed, in exchange for enhanced monitoring and supervision by the agency on their deployment.

This initiative comes at a time when more than 1,500 medical devices incorporating AI have already been approved by the FDA, but the bulk of these approvals are based on limited data: out of more than 1,300 approved devices, only three have been tested to measure direct clinical criteria such as mortality or morbidity. TEMPO aims to generate the clinical evidence that is currently lacking in real use.